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eLibrary > 23/30457003 DC BS EN 13795-2 Surgical clothing and drapes - Requirements and test methods - Part 2. Clean air suits >

23/30457003 DC BS EN 13795-2 Surgical clothing and drapes - Requirements and test methods - Part 2. Clean air suits, 2023

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23/30457003 DC BS EN 13795-2 Surgical clothing and drapes - Requirements and test methods - Part 2. Clean air suits, 2023

30457003-NC.pdf
41_e_stf (3).pdf [Go to Page]
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Manufacturing and processing requirements and documentation
6 Information to be supplied with the product [Go to Page]
6.1 Information to be supplied to the user
6.2 Information to be supplied to the processor
Annex A (normative)Testing [Go to Page]
A.1 General
A.2 Test methods and conformance [Go to Page]
A.2.1 Test method for evaluation of cleanliness microbial/bioburden
A.2.2 Test method for evaluation of particle release
A.2.3 Test method for evaluation of bursting strength in dry state
A.2.4 Test method for evaluation of tensile strength in dry state
A.2.5 Test method for evaluation of dry microbial penetration
A.2.6 Test method for evaluation of biocompatibility
A.3 Treatment of results
Annex B (informative)Rationales [Go to Page]
B.1 General
B.2 Cleanliness – microbial
B.3 Particle release
B.4 Bursting strength – dry
B.5 Tensile strength – dry
B.6 Resistance to microbial penetration – dry
B.7 Labelling
B.8 Treatment of results
B.9 Flammability
B.10 Electrostatic discharge
Annex C (informative)Environmental impact
Annex D (informative)Guidance to users for selecting products [Go to Page]
D.1 General
D.2 Performance levels
D.3 Functional design aspects [Go to Page]
D.3.1 Size
D.3.2 Accessories
D.4 Comfort [Go to Page]
D.4.1 General
D.4.2 Clean air suits
D.4.3 Practical trials
Annex E (informative)Functional design [Go to Page]
E.1 General
E.2 Test method for measuring source strength [Go to Page]
E.2.1 Dispersal chamber
E.2.2 Operating room
E.2.3 Measuring bacteria carrying airborne particles
E.2.4 Source strength
E.3 Use of source strength measurements
Annex ZA (informative)Relationship between this European standard and General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered [Go to Page]

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23/30457003 DC BS EN 13795-2 Surgical clothing and drapes - Requirements and test methods - Part 2. Clean air suits, 2023

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